HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer.

However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:

rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml [ Time Frame: one month after the last vaccination (week 28) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion [ Time Frame: one month after the last injection ( week 28) and month 18 ] [ Designated as safety issue: Yes ]

immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization [ Time Frame: at D0 ] [ Designated as safety issue: No ]

Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization

Exclusion Criteria:

Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients

Any vaccine received during the month preceding the inclusion

History of hypersensitivity to any component of GenHevac-B

acute opportunistic infection treated the month before the screening visit

Severe and acute pyretic infection or unexplained fever the week before inclusion

Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during at least 7 days) in the last 6 months before the screening visit

Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before the screening visit

Splenectomy

Decompensated cirrhosis (Child Pugh B or C)

Renal failure (creatinine clearance below 50 ml/mn)

Other severe immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months,….)

Any participation to another clinical trial plan until Week 28

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670839